Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 1:24 PM
Study NCT ID:
NCT02080767
Status:
AVAILABLE
Last Update Posted:
2025-03-06
First Post:
2014-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure
Sponsor:
U.S. Army Medical Research and Development Command
Organization:
Study Overview
Official Title:
Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses
Status:
AVAILABLE
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.
Detailed Description:
Rationale: Tecovirimat (TPOXX) is approved by FDA for treatment of smallpox. However, the therapeutic human dose for treatment of orthopox virus infections or a significant adverse reaction to vaccinia resulting from vaccination, secondary transmission, or other exposure, has not yet been fully established.
Treatment: Based on the interpretation of currently available animal efficacy and human safety and PK data, the proposed human adult or pediatric patient (≥ 40 kg) therapeutic regimen is 600 mg (3 capsules of 200 mg) orally twice daily (BID) for at least 14 days, taken 30 minutes after a meal consisting of about 600 calories and 30% (25 grams) fat, which is the same as treatment for smallpox. If a dose is missed it should be taken as soon as possible unless it is near the next dose time. Doses should not be doubled in the event of a missed dose. Treatment may be extended beyond 14 days, with sponsor approval, if the investigator deems necessary. Nonclinical safety data support use for up to 90 days.
The pediatric dosing recommendation is derived from the TPOXX package insert based on the body weight: 200 mg twice daily for patients of 13-25kg (29-45pounds); 400 mg twice daily for patients 25-40kg (55-87pounds) and 600 mg twice daily for pediatric patients over 40kg (88pounds)
Clinical Evaluation: Medical history and concomitant medications will be recorded, and a physical examination with vital signs \[eg, body weight, blood pressure, heart rate, respiratory rate, temperature, and height (only once)\] will be completed. Photographs of affected areas, should lesions develop, may be taken. Patients will be followed for at least 30 days after receiving the last tecovirimat dose or until their infection improves.
Treatment: Based on the interpretation of currently available animal efficacy and human safety and PK data, the proposed human adult or pediatric patient (≥ 40 kg) therapeutic regimen is 600 mg (3 capsules of 200 mg) orally twice daily (BID) for at least 14 days, taken 30 minutes after a meal consisting of about 600 calories and 30% (25 grams) fat, which is the same as treatment for smallpox. If a dose is missed it should be taken as soon as possible unless it is near the next dose time. Doses should not be doubled in the event of a missed dose. Treatment may be extended beyond 14 days, with sponsor approval, if the investigator deems necessary. Nonclinical safety data support use for up to 90 days.
The pediatric dosing recommendation is derived from the TPOXX package insert based on the body weight: 200 mg twice daily for patients of 13-25kg (29-45pounds); 400 mg twice daily for patients 25-40kg (55-87pounds) and 600 mg twice daily for pediatric patients over 40kg (88pounds)
Clinical Evaluation: Medical history and concomitant medications will be recorded, and a physical examination with vital signs \[eg, body weight, blood pressure, heart rate, respiratory rate, temperature, and height (only once)\] will be completed. Photographs of affected areas, should lesions develop, may be taken. Patients will be followed for at least 30 days after receiving the last tecovirimat dose or until their infection improves.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S-11-10 | OTHER | Sponsor | View |